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DOCUMENTATION ASSOCIATED TO THIS PROCEDURE:

[1] PB560 Product Requirements Doc (PRD) P/N 10035480
[2] PB560 Device History Record (DHR) P/N 10038461
[3] PB540 O2 Valve Leak Tester Setup, P/N 10023391
[4] PB500 Series System Calibration / Final Test Verification Log, P/N 10039304
[5] PB560 Pediatric Volume and Pressure Test Script, P/N 10039032
[6] PB560 Adult Volume and Pressure Test Script, P/N 10039033
[7] PB560 Volume and Pressure Tests, Manuf Test Spec, P/N 10040465
[8] Test Lung, Volume Determination Project Files # 3297 / M1288 / M1322
[9] OpenVent Software Specification Doc, P/N 10026043
[10] PB540 System Test Criteria Project File, # 3364
[11] PB540 Patient Circuit/Exhalation Valve Usage Log Sheet, P/N 10029922
[12] WEB SPC SYSTEM USER INSTRUCTION 10039404

PREPARED APPROVED
REV ECO DATE SUMMARY
BY BY
N/A N/A N/A Refer to 10039030 rev G for
N/A N/A
earlier revision history

H ECO-R245059 See Agile See Agile Updating instructions to

clarify on the steps required
under the “Test Note” of the
Volume and Pressure Tests’
section. Also, removal of the
Process monitoring as no
longer required.

J Update to clarify instruction

ECO-R254053 See Agile See Agile following review of
procedures versus practice

K Updates as per QAP056

EC045533 See Agile See Agile redlines, no change to
process.

Added instruction to
complete final test
equipment verification log
P/N 10039304. Move
instruction on alarm test daily
check, sound level meter
L EC075186 Refer to Agile Refer to Agile
(PN 10039030, pg.9) to front
of procedure. Move O2 valve
leak test (pg.3) and O2 valve
functional test box (pg.8) to
front (pg.3 & 7 of P/N
10036007).

Updated following G-
M EC102789 Refer to Agile Refer to Agile
QAP056 FY18 review
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TOOLING REQUIRED
Pentium Based PC with the OpenVent software P/N 10060473 loaded
Dual-limb Adult Patient Circuit with Exhalation Valve, DAR P/N 5094000 or approved equivalent
Dual-limb Pediatric Patient Circuit with Exhalation Valve, DAR P/N 5093900 or approved equivalent
Patient Hose, 22mm, 40cm length, P/N G-061440-00
, Pneuflo Resistor, Rp50, P/N 13394-03
, Pneuflo Resistor, Rp5, P/N 13394-05
Test Lung, 50 Litre bottle, See Doc Ref [8]
Test Lung, 3 Litre bottle, See Doc Ref [8]
PTS 2000 Performance Test Instrument with RS232 serial comm. cable
Sprint LC Multi Air Tester with 8mm tubing and PB540/PB560 O2 Inlet connector
FiO2 Sensor Kit, Airox P/N 3814199
Sound Level Calibrator Type 4231

TEST NOTES
1. If the ventilator fails any test step, describe the parameter out of spec in the Discrepancy Log of the DHR
and notify line technician or Manufacturing Engineer before switching off. Refer to procedure TBD.
2. The Alarm Silence Reset button may be used to suppress alarms as needed.
3. If at any time you notice an abnormality of any kind then notify the line Engineer/Technician for
clarification before continuing.
4. For each test section on the DHR, indicate Pass or Fail by signing initials in the appropriate Pass or Fail
column on the DHR.
5. Leave the PTS2000 switched ON. If the PTS2000 power switch is turned off and on, the pressure
transducers are automatically zeroed. Do not apply pressure to low or high pressure ports during power-
up. Wait approximately 10 minutes for the PTS2000 to warm-up.
6. Daily Check; Daily log checks to be completed at the start of each shift.

PRIOR TO COMMENCING TESTING ENSURE PB500 SERIES SYSTEM CALIBRATION / FINAL TEST
VERIFICATION LOG P/N 10039304 IS COMPLETED AS FOLLOWS;

ALARM TEST [REF [1] PRD174, PRD350, 193]

Daily Check: Sound Level Meter Check using the Breul & Kjaer meter and sound box
Prior to using the sound level meter for testing each day, check the sound level meter calibration by performing
the following steps:
1. Fit the Sound Level Calibrator Type 4231 carefully onto the sound level meter and rest the
assembly on a table or other flat surface.
2. Switch ON the sound level meter and ensure the LAF (LA Fast) parameter is displayed.
3. Switch ON the Sound Level Calibrator Type 4231, wait for the reading to settle and then check
that the sound level meter displays 93.6 to 94.2 dB (93.9 dB ± 0.3 dB). If not, do not continue testing
and contact Test Engineering.
4. Record the Cal ID and the sound level meter value on the PB500 Series System Final Test
Equipment Verification Log P/N 10039304.
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O2 VALVE LEAK TEST [REF [1] PRD38, REF [10] SEC 4.6]
Daily Check: Air Pressure Gauge Check
This check is to be performed once before testing each day. Verify that the air supply pressure gauge is set to
100-120psi and record the setting on the PB500 Series System Final Test Equipment Verification Log, P/N
10039304. If this check fails, stop testing and notify the Line Supervisor or Manufacturing Engineer.

O2 VALVE FUNCTIONAL TEST [REF [10] SEC 4.4]

Daily Check: O2 Source Pressure Gauge Check
These checks are to be performed once before testing each day. Verify that the O 2 source pressure gauge is
set to 1.5-2.0 bar and record the setting on the PB500 Series System Final Test Equipment Verification Log,
P/N 10039304. Also check that the flow-meter valve is fully open (CCW) and check the appropriate box on the
PB560 System Test Equipment Verification Log. If any of these checks fail, stop testing and notify the Line
Supervisor or Manufacturing Engineer.

VENTILATOR PRELIMINARY CHECKS

1. Check that the ventilator’s serial number agrees with the attached paperwork.
2. Ensure the device history package contains all the required sub-assembly testing.
3. Ensure the calibration documentation is complete.
4. Examine the ventilator for the following cosmetic deformities:
4.1 Ensure that there are no scratches, dents or other physical damage on the Ventilator housing.
4.2 Ensure that the 5 screws that secure the Housing are fitted to the lower side of the Ventilator.
4.3 Ensure that the battery housing screws and ventilator handle is fitted.
5. If any of the Checks fail in this section, then the result is Fail. Indicate the Pass or Fail test result
by signing initials in the appropriate column on the DHR.
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REAL TIME CLOCK TEST [REF [1] PRD203]

1. Connect the AC mains cable to the Ventilator and verify that the AC Power LED is illuminated.
2. Switch the AC Power Switch at the rear of the Ventilator OFF and then ON.
3. Press and hold the Alarm Silence button to enter the Setup Mode. Release button when the setup menu
is displayed on Ventilator screen.
NOTE: If a BUZZER FAULT1 alarm event occurs, contact the line technician.
LINE TECH NOTE: The BUZZER FAULT1 alarm can be triggered if the alarm inhibition button is
pressed (during the initialization buzzer test) on vent power-up. If the vent passes the Involuntary Stop
Alarm Test, Buzzer Sound Level Check in the 10036007 procedure and this alarm event is cleared when
the vent is power cycled, then this alarm event is not considered a failure.

4. Check that the vent Date is current and that the vent Time is equivalent to the plant clock ± 1 minute.
5. Switch the AC Power Switch at the rear of the Ventilator OFF.
.

O2 VALVE LEAK TEST [REF [1] PRD38, REF [10] SEC 4.6]

Test Procedure:
1. Connect the tubing from the Sprint LC Multi Air Tester #1 test port to the O2 Inlet at the rear of the
ventilator.
2. Turn the ventilator power ON and ensure the ventilator is not ventilating.
3. On the Sprint LC Multi Air Tester press the square white button to start the test.
4. When the test has finished, record the Sprint LC Multi Air Tester leak measurement value (Leak Tester
Reading) on the DHR.
NOTE:
This measurement is indicated to the right of ‘Ch 1’ on the Sprint leak tester screen. Limit: <0.073 psig.
5. .Disconnect the tubing from the O2 Inlet at the rear of the ventilator.
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FiO2 SENSOR DETECTION TEST [REF [1] PRD288a]

TEST NOTE:
Maximum service life of the FiO2 Sensor is 12 months starting from date of manufacture.
For initial use of an FiO2 Sensor attach a label showing the Manufacture Date as indicated
on the sensor packaging then add 12 months to this date to obtain the End-Use date and
record this on the label also.

NOTE: The FiO2 sensor needs to be calibrated for each vent used for testing the FiO2.

FiO2 Sensor Calibration

1) Connect the FiO2 Sensor and cable to the PB560 ventilator as shown the picture below. Do not connect
the Inspiratory Cap Test Assembly at this time.

FiO2 Sensor Unit

2) Turn ON the ventilator if not already on, and press the Menu key to enter the Alarm menu.
3) Move the cursor to the FiO2 % row, and then press the Accept key twice to move to the ‘Current’ column.
4) Press the up arrow key to select YES and then the Accept key to perform the calibration operation.
5) If no calibration errors are displayed, then the calibration is successful.
6) Indicate the Pass or Fail test result by signing initials in the appropriate Pass or Fail column on the DHR.
7) Exit the Alarm menu to return to the ventilation menu.
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FiO2 Sensor Detection Test
1) Connect the Inspiratory Cap Test Assembly to the FiO 2 Sensor as shown in the picture below.

FiO2 Sensor Unit

Inspiratory Cap Test Assembly

2) Press on the ventilation  key to start ventilation

3) Check that the vent FiO2 reading is 19-23 % (21 % ± 2), and Record the reading on the DHR.
4) Disconnect the FiO2 cable from the vent Inspiratory block, and Check for a ‘FiO2 Sensor Missing’ message
is displayed on the vent.
5) Indicate the Pass or Fail test result by signing initials in the appropriate Pass or Fail column on the DHR.
6) Turn off the ventilation from the set-up menu.
• To turn off ventilation press and hold the VENTILATION ON/OFF key for three seconds. see fig 1 & 2.
• A double ‘beep’ sounds, then release the VENTILATION ON/OFF key. A second screen appears to
confirm ‘stop ventilation’ (see fig 3).
• Press the VENTILATION ON/OFF key within 5 seconds to confirm STOP (otherwise ventilation will
continue.
• Ventilation stops & the LED located to the upper-right of the VENTILATION ON/OFF key illuminates to
indicate ventilation is on standby.
LED for ventilation standby - No 2
Fig 1

VENTILATION ON/OFF key- No 1

Fig 2 Fig 3

7) Press the Alarm Silence button to silence the Intentional Vent Stop alarm.
8) Disconnect the Inspiratory assembly and FiO2 Sensor from the vent.
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VOLUME AND PRESSURE TESTS [Ref Doc 7]

Fig.1 Connection of the patient circuit Fig.2 Connection of Patient hose to 3L Test Lung
for the volume and pressure test

Test Note: During the Paediatric and Adult Volume and Pressure Testing, the PB560 will
display the Intentional Vent Stop Alarm when ventilation is switched OFF and the alarm
will cease when ventilation is resumed. This is normal behaviour for the PB560.

Paediatric Volume and Pressure Tests

1. Connect the mini-USB cable from the PC to the vent.
2. Connect the PAEDIATRIC patient circuit tubing ‘Y’ end to the PTS2000 high flow inlet as shown in
Figure.1 with the exhalation valve connected on the side of the vent with the arrow on the valve pointing
out.
3. Connect the patient hose from the 3L test lung, to the high flow exhaust port at the back of the PTS2000,
as in Fig.2.
4. Connect the patient tubing proximal pressure tubing to the PTS2000 Low Pressure (+) and the patient
pressure vent port using a ‘T’ connection, connect the two remaining tubes to vent as per figure 1.
5. Ensure the PTS2000 is set for Remote Operation using the PTS2000 ▼▲ buttons.
6. Switch the ventilator power ON (if not already ON) and then select and enter the Preferences menu.
7. Confirm that ‘Pediatric Circuit’ option is YES, and then return to the Ventilation menu. Confirm
on DHR.
8. Press the Menu button to enter the alarm limits menu.
9. Place the cursor on the VTE row, and press √ Accept twice.
10. Press the ▲up arrow to select yes and press √ Accept to perform the Exp Flow Calibration.
11. Check that no CAL FAULT messages are displayed on the vent LCD.
12. Press the Menu button to return to the main menu.
13. Click on the PC desktop PB560 PAEDIATRIC Test Script icon to run the tests.
14. When the tests are finished, press the Alarm Silence button to silence the Intentional Vent Stop Alarm.
15. Check the test report test result and indicate the Pass or Fail test result by signing initials in the
appropriate Pass or Fail column on the DHR.
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16. From the Ventilation menu, select and enter the Preferences menu.
17. Set the ‘Paediatric Circuit’ option to OFF, and then return to the Ventilation menu.
18. Print the Test Report, Sign and Date the Test Report Title Page at the bottom and attach to the DHR.
19. Disconnect the paediatric patient circuit tubing from the vent and the 3 L test lung from the PTS2000.

Adult Volume and Pressure Tests

1. Connect the mini-USB cable from the PC to the vent, if not already connected.
2. Connect the ADULT patient circuit tubing ‘Y’ end to the PTS2000 high flow inlet as shown in Fig. 1 with the
exhalation valve connected on the side of the vent with the arrow on the valve pointing out.
3. Connect the patient hose from the 50L test lung, to the high flow exhaust at the back of the PTS2000.
4. Connect the patient tubing proximal pressure tubing to the PTS2000 Low Pressure (+) and the patient
pressure vent port using a ‘T’ connection. Connect the two remaining tubes to the Vent as per Fig.1 on
previous page.
5. Ensure the PTS2000 is set for Remote Operation using the PTS2000 ▼▲ buttons.
6. On DHR confirm that Paediatric Circuit is set to NO.
7. Press the Menu button to enter the alarm limits menu.
8. Place the cursor on the VTE row, and press √ Accept twice.
9. Press the ▲up arrow to select yes and press √ Accept to perform the Exp Flow Calibration.
10. Check that no CAL FAULT messages are displayed on the vent LCD.
11. Press the Menu button to return to the MAIN MENU.
12. Click on the PC desktop PB560 ADULT Test Script icon to run the tests.
13. When the tests are finished, press the Alarm Silence button to silence the Intentional Vent Stop Alarm.
14. Check the test report test result and indicate the Pass or Fail test result by signing initials in the
appropriate Pass or Fail column on the DHR.
15. Print the Test Report, Sign and Date the Test Report Title Page at the bottom and attach to the DHR.
16. Do NOT remove the adult patient circuit tubing and the 50L test lung from the PTS2000.
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O2 VALVE FUNCTIONAL TEST [REF [10] SEC 4.4]

1. Using the PTS2000 ▼▲ buttons, select and display the Oxygen measurement on the PTS 2000.
2. Ensure the Oxygen supply valve located in the flexible hose is turned OFF.
3. Connect the Oxygen supply hose to the Oxygen inlet at the rear of the ventilator.
4. Set the ventilation mode to P A/C.
5. Set the vent PIP to 30 mbar.
6. Set the vent Rate to 15.
7. On DHR confirm settings, (Mode = A/C, Pi = 30 mbar & Rate = 15).

8. Press on the ventilation  key to start ventilation.

9. Check that the PTS2000 Oxygen reading is 18-24% (21% ± 3%). Record the Oxygen reading on the
DHR.
10. Turn ON the Oxygen supply valve.
11. Check that the PTS2000 reading is greater than 30 % after 10 breath cycles of ventilation.
12. Record the PTS2000 % Oxygen reading on the DHR.
13. Check that the Ventilation Led is OFF.
14. Check that air escapes at the exhalation block during the exhale phase.
15. Indicate the Pass or Fail test result by signing initials in the appropriate Pass or Fail column on the DHR.
16. Turn OFF the Oxygen supply valve and then disconnect the Oxygen supply hose from the ventilator.
Turn off the ventilation from the set-up menu.
• To turn off ventilation press and hold the VENTILATION ON/OFF key for three seconds. See fig 1 & 2.
• A double ‘beep’ sounds, then release the VENTILATION ON/OFF key. A second screen appears to
confirm ‘stop ventilation’ see fig 3.
• Press the VENTILATION ON/OFF key within 5 seconds to confirm STOP (otherwise ventilation will
continue.
• Ventilation stops & the LED located to the upper-right of the VENTILATION ON/OFF key illuminates to
indicate ventilation is on standby.

LED for ventilation standby - No 2

Fig 1

VENTILATION ON/OFF key- No 1

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Fig 3
Fig 2

17. Press the Alarm Silence button to silence the Intentional Vent Stop alarm.
18. Disconnect the adult patient circuit tubing from the vent and the 50 L test lung from the PTS2000.

DEFAULT PARAMETER SETTING

1. Ensure the following default parameters are set on the Ventilator:
Ventilation Mode = P A/C
P = 15mbar
PEEP = OFF
Rise Time =2
Rate = 13 breaths/min
I:E = 1:2.0 (Insp Time = 1.5 sec)
Insp Sens =2
Vt Target = OFF
2. Enter the Preferences menu and ensure the Alarm Level is set to 100 % (maximum).
3. In the Preferences menu ensure the LCD Backlight setting is set to OFF.
4. Indicate the Pass or Fail test result by signing initials in the appropriate Pass or Fail column on the DHR
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CLEAR VENTILATOR LOGS [REF [1] PRD208, 209]

1. Check the Alarm History Log for any events during the test that are not related to normal operation
activities.
2. Switch ventilator power OFF then ON and press Alarm Reset to enter Setup Mode.
3. Place cursor on Maintenance option and accept.
4. Place the cursor on Faults Check and press the accept button.
5. Check the Faults Checklist to be empty. If the list is not empty, check the events listed and record on the
DHR any faults not being triggered by normal operation activities.
Refer to Appendix A for a listing of potential causes of the fault.
6. Place the cursor on Back and press the accept button to exit
7. If the vent has failed any test step in system calibration or final testing that has not been fixed,
then do not perform the next step which clears the vent logs and skip to Step 9 below.
8. With the cursor at Faults Check, reset the alarm history by pressing and holding the Alarm Reset
button until a long beep sounds. The alarm history is now cleared.
9. Record a Fail result if an unexpected fault was listed, otherwise record Pass result on the DHR.

DHR Section Signoff: Sign and Date the DHR.

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APPENDIX A: Error Listing

Error Number Fault Fault Resolution

N°1
Inspiratory flow measurement fault Calibrate the flow sensor

N°2 Calibration of the inspiratory flow

Calibrate the inspiratory flow sensor
sensor is not compliant

N°3 Calibration of the expiratory flow

Calibrate the expiratory flow sensor
sensor is not compliant

N°4 Calibration of the valve pressure

Calibrate the valve pressure sensor
sensor is not compliant

N°5 Calibration of the patient pressure

Calibrate the patient pressure sensor
sensor is not compliant

N°6
Abnormal Turbine speed Change the Turbine or CPU card

N°7 Update the date and time again or change

Loss of the clock parameters the battery on the CPU card or change the
CPU card

N°8 Calibration of the proximal pressure

Calibrate the proximal pressure sensor
sensor is not compliant

N°9
Low Proximal Pressure Change the CPU card

N°10
Low Internal Pressure Change the CPU card

N°11
Low Valve Pressure Change the CPU card

N°12
Event Log Error Change the CPU card